Methods of measuring symptoms of chronic rhinosinusitis

Abstract

A method for diagnosing, assessing, and determining of the efficacy of a treatment regimen for chronic rhinosinusitis is presented. The method comprises collecting subjective information from a patient or patient population in the form of patient entries into a daily diary, wherein the daily diary comprises the patient responses to questions directed to the presence or absence of a group of clinical signs and symptoms related to chronic rhinosinusitis. Based upon the patient responses in the daily diaries, certain of the clinical signs and symptoms are identified for use in the generation of a scoring tool useful in the determination and assessment of the efficacy of a treatment regimen for chronic rhinosinusitis, as well as in the clinical determination of the severity of the symptoms related to chronic rhinosinusitis.

1 . A method for determining the efficacy of a treatment regimen for chronic rhinosinusitis, said method comprising the steps of: 
 (a) conducting at least two interviews of one or more patients over the duration of a treatment regimen to collect patient-reported information specific to clinical severity of one or more of a plurality of symptoms related to chronic rhinosinusitis in said one or more patients;    (b) said at least two interviews comprising said one or more patients assigning an individual symptom score for each of said one or more symptoms within said plurality of symptoms at the time of said interviews;    (c) selecting two or more individual symptoms of said plurality of symptoms for use in calculating a composite score which reflects clinical status of said chronic rhinosinusitis in said one or more patients at the time said interview was conducted;    (d) calculating a composite score based upon the value of said two or more individuals symptoms of step (c) to obtain a sum value which reflects the clinical status of said chronic rhinosinusitis in said patient at the initiation of said treatment regimen;    (e) calculating a composite score based upon the value of said two or more individuals symptoms of step (c) to obtain a sum value which reflects the clinical status of said chronic rhinosinusitis in said patient at a time point after the initiation of said treatment regimen; and    (f) comparing sum values of steps (d) and (e) to determine the efficacy of said treatment regimen.    
     
     
         2 . The method of  claim 1 , wherein said interviews are conducted daily over the duration of said treatment regimen.  
     
     
         3 . The method of  claim 1 , wherein said interviews comprise collecting said patient-reported information in the form of responses to a set of oral questions, collecting said patient-reported information in the form of responses to a set of questions contained in written questionnaire, collecting said patient-reported information in the form of responses to a set of questions in a telephone survey, collecting said patient-reported information in the form of responses to a set of questions in fax survey, collecting said patient-reported information in the form of responses to a set of questions in an Internet questionnaire to be submitted via the Internet, or by having said one or more patients directly input their responses to a set of questions contained in a questionnaire into a computer database.  
     
     
         4 . The method of  claim 1 , wherein said interviews comprise collecting patient-reported information in the form of patient responses to a set of questions contained in a written questionnaire.  
     
     
         5 . The method of  claim 1 , wherein said plurality of symptoms related to chronic rhinosinusitis comprises at least one of: (1) facial or sinus pressure, (2) facial or sinus pain, (3) nasal congestion, (4) postnasal drip, (5) sinus headache, and (6) tiredness/fatigue.  
     
     
         6 . The method of  claim 1 , wherein said individual symptom score comprises a subjective self-assessment of the symptom translated to a number for each of said plurality of symptoms related to chronic rhinosinusitis.  
     
     
         7 . The method of  claim 6 , wherein the number is selected from an individual symptom score scale representative of the clinical status of the chronic rhinosinusitis symptom being assessed.  
     
     
         8 . The method of  claim 6 , wherein said individual symptom score scale comprises a four point scale that is divided in increments of 1.  
     
     
         9 . The method of  claim 7 , wherein said individual symptom score scale further comprises a numerical value corresponding to the severity of the symptom; 0 being no indication of the symptom (none), 1 being mild indication of the symptom (mild), 2 being moderate indication of the symptom (moderate), and 3 being severe indication of the symptom (severe).  
     
     
         10 . The method of step (c) of  claim 1 , wherein said two or more individual symptoms are selected for use in said calculating composite score based upon the validation of each of said at least two individual symptoms' relevance to said clinical severity of chronic rhinosinusitis in said one or more patients.  
     
     
         11 . The method of  claim 10 , wherein said validation is determined by statistical analysis of the patent-reported information of steps (a) and (b).  
     
     
         12 . The method of  claim 1  step (c), wherein two individual symptoms are selected for use in calculating said composite score.  
     
     
         13 . The method of  claim 1  step (c), wherein three individual symptoms are selected for use in calculating said composite score.  
     
     
         14 . The method of  claim 1  step (c), wherein four individual symptoms are selected for use in calculating said composite score.  
     
     
         15 . The method of  claim 1  step (c), wherein five individual symptoms are selected for use in calculating said composite score.  
     
     
         16 . The method of  claim 1  step (c), wherein six individual symptoms are selected for use in calculating said composite score.  
     
     
         17 . The method of  claim 1  step (d), wherein said calculating a composite score comprises adding together the individual symptom scores of said two or more individual symptoms selected in step (c) to obtain a sum value which reflects the clinical status of said chronic rhinosinusitis in said one or more patients at the initiation of said treatment regimen.  
     
     
         18 . The method of  claim 1  step (e), wherein said calculating a composite score comprises adding together the individual symptom scores of said two or more individual symptoms selected in step (c) to obtain a sum value which reflects the clinical status of said chronic rhinosinusitis in said one or more patients at a time point after the initiation of said treatment regimen.  
     
     
         19 . The method of  claim 1 , wherein step (f) comprises calculating the p value of the change in composite scores of steps (d) and (e) in a patient population as compared to the change in composite scores of steps (d) and (e) in a patient population given a placebo or an alternate therapy.  
     
     
         20 . The method of  claim 1 , wherein step (f) comprises identifying said treatment regimen as highly effective, effective, moderately effective, or not effective.  
     
     
         21 . The method of  claim 1 , wherein said treatment regimen comprises the administration of an active agent at a specific dosage for the treatment of chronic rhinosinusitis over a defined period of time.  
     
     
         22 . The method of  claim 1 , wherein said method is used to compare the efficacy of one or more distinct dosages of an active agent in treating chronic rhinosinusitis.  
     
     
         23 . The method of  claim 1 , wherein said method is used to compare the efficacy of one or more distinct active agents in treating chronic rhinosinusitis.  
     
     
         24 . The method of  claim 1 , further comprising building a predictive model to determine a patient's healthcare outcome to a particular treatment regimen.  
     
     
         25 . The method of  claim 1 , further comprising building a predictive model to determine a patient population's healthcare outcome to a particular treatment regimen.  
     
     
         26 . A method for the assessment of chronic rhinosinusitis, said method comprising the steps of: 
 (a) conducting at least two interviews of with said one or more patients over the duration of a treatment regimen to collect patient-reported information specific to clinical severity of one or more of a plurality of symptoms related to chronic rhinosinusitis in said one or more patients;    (b) said at least two interviews comprising said one or more patients assigning an individual symptom score for each of said one or more symptoms within said plurality of symptoms at the time of said interview;    (c) selecting two or more individual symptoms of said plurality of symptoms for use in calculating a composite score which reflects clinical status of said chronic rhinosinusitis in said one or more patients at the time said interview was conducted;    (d) calculating a composite score based upon the value of said two or more individuals symptoms of step (c) to obtain a sum value which reflects clinical status of said chronic rhinosinusitis in said patient at the initiation of said treatment regimen;    (e) calculating a composite score based upon the value of said two or more individuals symptoms of step (c) to obtain a sum value which reflects clinical status of said chronic rhinosinusitis in said patient at a time point after the initiation of said treatment regimen;    (f) comparing sum values of steps (d) and (e) to assess chronic sinusitis in said one or more patients.    
     
     
         27 . The method of  claim 26 , wherein said interviews are conducted daily over the duration of said treatment regimen.  
     
     
         28 . The method of  claim 26 , wherein said interviews comprise collecting said patient-reported information in the form of responses to a set of oral questions, collecting said patient-reported information in the form of responses to a set of questions contained in written questionnaire, collecting said patient-reported information in the form of responses to a set of questions in a telephone survey, collecting said patient-reported information in the form of responses to a set of questions in fax survey, collecting said patient-reported information in the form of responses to a set of questions in an Internet questionnaire to be submitted via the Internet, or by having said one or more patients directly input their responses to a set of questions contained in a questionnaire into a computer database.  
     
     
         29 . The method of  claim 26 , wherein said interviews comprise collecting patient-reported information in the form of patient responses to a set of questions contained in a written questionnaire.  
     
     
         30 . The method of  claim 26 , wherein said plurality of symptoms related to chronic rhinosinusitis comprises at least one of: (1) facial or sinus pressure, (2) facial or sinus pain, (3) nasal congestion, (4) postnasal drip, (5) sinus headache, and (6) tiredness/fatigue.  
     
     
         31 . The method of  claim 26 , wherein said individual symptom score comprises a subjective self-assessment of the symptom translated to a number for each of said plurality of symptoms related to chronic rhinosinusitis.  
     
     
         32 . The method of  claim 31 , wherein the number is selected from an individual symptom score scale representative of the clinical status of the chronic rhinosinusitis symptom being assessed.  
     
     
         33 . The method of  claim 32 , wherein said individual symptom score scale comprises a four point scale that is divided in increments of 1.  
     
     
         34 . The method of  claim 33 , wherein said individual symptom score scale further comprises a numerical value corresponding to the severity of the symptom; 0 being no indication of the symptom (none), 1 being mild indication of the symptom (mild), 2 being moderate indication of the symptom (moderate), and 3 being severe indication of the symptom (severe).  
     
     
         35 . The method of step (c) of  claim 26 , wherein said two or more individual symptoms are selected for use in said calculating composite score based upon the validation of each of said at least two individual symptoms' relevance to said clinical severity of chronic rhinosinusitis in said patient.  
     
     
         36 . The method of  claim 35 , wherein said validation is determined by statistical analysis of the patent-reported information of steps (a) and (b).  
     
     
         37 . The method of  claim 26 , wherein the assessment of chronic rhinosinusitis comprises assessing the response of a patient to a particular treatment regimen.  
     
     
         38 . The method of  claim 26 , wherein the assessment of chronic rhinosinusitis comprises assessing the response of a patient population to a particular treatment regimen.  
     
     
         39 . The method of  claim 26 , further comprising the step (g) of comparing the composite scores of step (f) to a previously calculated composite score from the same patient.  
     
     
         40 . The method of  claim 39 , wherein comparing the composite score to a previously calculated composite score from the same patient further comprises calculating the difference between the composite score and a previously calculated composite score from the same patient.  
     
     
         41 . The method of  claim 26 , further comprising calculating the difference between a mean composite score in a patient population and a previously calculated mean composite score in the same patient population.  
     
     
         42 . A method for determining the severity of symptoms related to chronic rhinosinusitis in a patient, said method comprising the steps of: 
 (a) conducting at least two interviews of with said patient over the duration of a pre-determined period of time to collect patient-reported information specific to the clinical severity of one or more of a plurality of symptoms related to chronic rhinosinusitis;    (b) said at least two interviews comprising said patient assigning an individual symptom score for each of said one or more symptoms within said plurality of symptoms at the time of said interview;    (c) selecting two or more individual symptoms of said plurality of symptoms for use in calculating a composite score which reflects clinical status of said chronic rhinosinusitis in said patient at the time said interview was conducted;    (d) calculating a composite score based upon the value of said two or more individuals symptoms of step (c) to obtain a sum value which reflects clinical status of said chronic rhinosinusitis in said patient at the time of the first interview;    (e) calculating a composite score based upon the value of said two or more individuals symptoms of step (c) to obtain a sum value which reflects clinical status of said chronic rhinosinusitis in said patient at a time point after the first interview;    (f) comparing sum values of steps (d) and (e) to determine the severity of the symptoms related to chronic rhinosinusitis in said patient.    
     
     
         43 . The method of  claim 42 , wherein said interviews are conducted daily over the duration of said predetermined period of time.  
     
     
         44 . The method of  claim 42 , wherein said interviews comprise collecting said patient-reported information in the form of responses to a set of oral questions, collecting said patient-reported information in the form of responses to a set of questions contained in written questionnaire, collecting said patient-reported information in the form of responses to a set of questions in a telephone survey, collecting said patient-reported information in the form of responses to a set of questions in fax survey, collecting said patient-reported information in the form of responses to a set of questions in an Internet questionnaire to be submitted via the Internet, or by having said one or more patients directly input their responses to a set of questions contained in a questionnaire into a computer database.  
     
     
         45 . The method of  claim 42 , wherein said interviews comprise collecting patient-reported information in the form of patient responses to a set of questions contained in a written questionnaire.  
     
     
         46 . The method of  claim 42 , wherein said plurality of symptoms related to chronic rhinosinusitis comprises at least one of: (1) facial or sinus pressure, (2) facial or sinus pain, (3) nasal congestion, (4) postnasal drip, (5) sinus headache, and (6) tiredness/fatigue.  
     
     
         47 . The method of  claim 42 , wherein said individual symptom score comprises a subjective self-assessment of the symptom translated to a number for each of said plurality of symptoms related to chronic rhinosinusitis.  
     
     
         48 . The method of  claim 47 , wherein the number is selected from an individual symptom score scale representative of the clinical status of the chronic rhinosinusitis symptom being assessed.  
     
     
         49 . The method of  claim 47 , wherein said individual symptom score scale comprises a four point scale that is divided in increments of 1.  
     
     
         50 . The method of  claim 48 , wherein said individual symptom score scale further comprises a numerical value corresponding to the severity of the symptom; 0 being no indication of the symptom (none), 1 being mild indication of the symptom (mild), 2 being moderate indication of the symptom (moderate), and 3 being severe indication of the symptom (severe).  
     
     
         51 . The method of step (c) of  claim 42 , wherein said two or more individual symptoms are selected for use in said calculating composite score based upon the validation of each of said at least two individual symptoms' relevance to said clinical severity of chronic rhinosinusitis in said patient.  
     
     
         52 . The method of  claim 51 , wherein said validation is determined by statistical analysis of the patient-reported information of steps (a) and (b).  
     
     
         53 . The method of  claim 42 , further comprising the step (g) of comparing the composite score to known diagnostic criteria.  
     
     
         54 . The method of  claim 53 , wherein comparing the composite score to known diagnostic criteria further comprises statistical analyses.  
     
     
         55 . The method of  claim 53 , further comprising comparing the composite score to known diagnostic criteria in a lookup table.  
     
     
         56 . The method of  claim 53 , further comprising a determination of whether chronic rhinosinusitis in a patient is in a mild, moderate, or severe stage of disease progression.